Practical insights on regulatory affairs, quality management and business development in medical technology.
When is AI in a medical device high-risk AI, which obligations follow, and how did the Digital Omnibus change the deadlines? An overview for manufacturers and software teams.
How does ISO 13485 certification work? A step-by-step guide from gap analysis to Stage 1 and Stage 2 audits and the certificate, plus the most common pitfalls.
How medical device classification works under MDR Annex VIII: classes I, IIa, IIb and III, the 22 rules, software under Rule 11 and common mistakes.
Which cybersecurity obligations apply to medical devices and their manufacturers? MDR Annex I, MDCG 2019-16, IEC 81001-5-1, the Cyber Resilience Act and NIS2 put into context.
What do medical device manufacturers expect from suppliers and contract manufacturers? ISO 13485, quality agreements, process validation, change notification and audits explained.
How medical device manufacturers prepare for initial, surveillance and unannounced notified body audits under the MDR. Includes a checklist and practical tips for audit day.